The in-vitro porcine adhesion model is not predictive of the esophageal transit of risedronate tablets in humans

Mucosal damage due to esophageal adhesion of pharmaceuticals is a continued concern to both health care providers and drug manufacturers. As a result of this concern, dosage forms are now being designed to exhibit minimal eso phageal adhesion. Previous researchers have used an in-vitro porcine esopha geal model to determine the propensity for formulations to adhere to the es ophagus as an alternative to human scintigraphy studies. This study used a porcine esophageal adhesion model similar to that used previously to determ ine the adhesiveness of placebo bisphosphonate formulations. Results are an alogous to those obtained by previous researchers, with film-coated tablets showing greater adhesiveness than uncoated tablets. These same tablet form ulations were also evaluated previously by a human scintigraphy study, and the results were exactly opposite of those obtained using the in-vitro porc ine model. In the human scintigraphy study, the film-coated placebo risedro nate tablet had a faster transit time than an uncoated round placebo tablet . In conclusion, the in-vitro porcine esophageal model is not predictive of esophageal transit in man and gamma scintigraphy is the preferred method t o evaluate esophageal transit. (C) 2001 Elsevier Science B.V. All rights re served.